amorphOX® - a novel and inventive drug delivery platform 

Orexo has successfully developed a drug delivery platform, amorphOX®, which is a novel and inventive nasal powder technology, that is very rapidly dissolving and stable. As amorphOX® works with different APIs, dosage forms and administration routes it is a versatile platform with significant potential.

Amorphous solids are non-crystalline solids, and possess no long-range order, giving them unique and highly sought-after properties, such as very rapid dissolution in water. These properties enable formulation of drugs in a manner that allows for a faster onset and a higher bioavailability. Historically however, amorphous drug compositions were found to be both chemically and physically unstable and therefore to degrade during storage. Orexo has a solution to this problem with the development of a drug delivery platform. The platform, named amorphOX®, is a nasal powder technology that is both chemically and physically stable when stored in even elevated temperatures, while still being rapidly dissolving.

A versatile drug delivery platform

The nasal powder technology is made up of particles which are built using a unique combination of a drug, carrier materials and, optionally, other excipients such as a permeability enhancer. The particles are presented as an amorphous composite of the various ingredients providing for excellent chemical and physical stability. The surface structure can be tuned for optimal process ability, and the size of the particle can be tailored to suite different administration routes.

Orexo is in the process of developing the amorphOX® platform to formulate and administer naloxone (OX124) and nalmefene (OX125) to reverse opioid overdoses. The number of deaths from opioid overdoses have grown in recent years, particularly in the US, creating a need for new and improved rescue medications, particularly for overdoses caused by synthetic opioids such as fentanyl.

Validated in humans

The technology has successfully been proven in multiple clinical studies. It is validated in the development of various rescues medications including naloxone (OX124), nalmefen (OX125) and epinephrine (OX640), a treatment for allergic reactions. All use nasal delivery. Data has demonstrated it is rapidly dissolving, has excellent bioavailability and both chemical and physical stability.

Wide applicability

The amorphOX® platform has also shown good results in accelerated stability studies when used with numerous other APIs with very different chemical structures. The nasal powder technology also supports various dosage forms and administration routes and the properties of the powder can be tailored to meet specific needs such as particle size, dissolution, and mucosal retention. This makes it a versatile technology with broad applicability in pharmaceutical development across multiple therapeutic areas.